USPTO Patents Application 09623138

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria, Virginia 22313-1450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

09/623,138

08/28/2000

1444 7590 02/04/2004

browdy and neimark, p.l.l.c.

624 NINTH STREET, NW
SUITE 300

WASHINGTON, DC 20001-5303

Shigeru Kinoshita

KINOSHITA3

9673

EXAMINER

HUI, SAN MING R

ART UNIT

PAPER NUMBER

1617

DATE MAILED: 02/04/2004

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

Office Action Summary

Application No.

09/623,138

Applicant(s)

KINOSHITA, SHIGERU

Examiner

San-ming Hui

Art Unit

1617

The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 1 33).

- Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1 )I3 Responsive to communication(s) filed on 22 November 2003 .
2a)|3 This action is FINAL. 2b)D This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 1 1 , 453 O.G. 213.

Disposition of Claims

4) 13 Claim(s) 11.14.15.17,19 and 20 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) D Claim(s) is/are allowed.

6) |EI Claim(s) 11. 14. 15. 17. 19 and 20 is/are rejected.

7) D Claim(s) is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10)D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
1 1 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-1 52.
Priority under 35 U.S.C. §§119 and 120

12)S Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f)
a)KlAII b)D Some*c)D None of:

Certified copies of the priority documents have been received.
Certified copies of the priority documents have been received in Application No.

10
2.D
3.ISI

Copies of the certified copies of the priority documents have been received in this National Stage
application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

13) D Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application)

since a specific reference was included in the first sentence of the specification or in an Application Data Sheet.
37 CFR 1.78.

a) □ The translation of the foreign language provisional application has been received.

14) D Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121 since a specific

reference was included in the first sentence of the specification or in an Application Data Sheet. 37 CFR 1 .78.

Attachment(s)

1) □ Notice of References Cited (PTO-892)

2) O Notice of Draftsperson's Patent Drawing Review (PTO-948)

3) □ Information Disclosure Statement(s) (PTO-1449) Paper No(s).

4) □ Interview Summary (PTO-413) Paper No(s).

5) □ Notice of Informal Patent Application (PTO-1 52)

6) □ Other:

U.S. Patent and Trademark Office
PTOL-326 (Rev. 11-03)

Office Action Summary

Part of Paper No. 15

Application/Control Number: 09/623,138 Page 2

Art Unit: 1617

DETAILED ACTION

Applicant's amendments filed November 22, 2003 have been entered.
The outstanding rejection under 35 USC 112, first paragraph is withdrawn in view
of the amendments filed November 22, 2003.

Claims 11, 14, 15, 17, 19 and 20 are pending.

Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
obviousness rejections set forth in this Office action:

(a) A patent may not be obtained though the invention is not identically disclosed or described as set
forth in section 102 of this title, if the differences between the subject matter sought to be patented and
the prior art are such that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said subject matter pertains.
Patentability shall not be negatived by the manner in which the invention was made.

Claims 11, 14-15, 17, and 19-20 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Paul (Fundamental Immunology, 3 rd ed., 1993, Raven Press, page
119-121), Niederkorn et al. (Abstract of Reg. Immunol., 1989 ; 2(2) : 83-90), Dam et al.
(Journal of Investigational Dermatology Symposium proceedings; 1996;1(1):72-77) and
Muller et al. (Journal of Investigational Dermatology Symposium proceedings;
1996; 1(1): 68-71) in view of Itoh et al. (WO96/29079, the English translation, Patent US
6,248,732, is also provided), and Hingorani et al. (Drugs 1995; 50(2); 208-221),
references in the previous office action.

Paul teaches Langerhans cells (LC) is an antigen presenting cells that is highly
effective in presenting antigen to T cells (See page 120, col. 1 ). Paul also teaches that

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Art Unit: 1617

IL-1 increases the antigen presenting function of LC to T cells (See page 120, col. 1 ,
fifth paragraph).

Niederkorn et al. teaches that LC is present in corneal epithelium and could
migrate to the central cornea upon irritants or the presence of IL-1 (See the abstract).

Dam et al. also teaches calcitriol or calcipotriol inhibit TNF-a, a factor which can
induce migration of LC, which is a type of antigen presenting cell (See page 76, col. 1 ,
second paragraph). Dam et al. teaches calcitriol and calcipotriol are useful to suppress
the number of LC when applied topically (See particularly page 72, col. 2, last
paragraph). Dam et al. also teaches calcitriol and calcipotriol suppress the T-cell
proliferation (See page 75, col. 2, first paragraph).

Muller et al. teaches the calcitriol inhibits the production of interleukin-1 at a
presecretory level such as reducing the levels of interleukin-1 a mRNA, which is known
to activate lymphocytes (See page 68, col.2, third paragraph).

The references do not expressly teach calcitriol is in a form of ophthalmic
solution. The references do not expressly teach calcitriol is useful in treating
keratoconjuctivitis, phlyctenular keratitis, or corneal infiltration. The references do not
expressly teach calcitriol is useful in a method to inhibit interleukin-1 production in
cornea epithelium and thereby treat ocular inflammation.

Itoh et al. teaches that calcitriol can be formulated into an ophthalmic
composition (See See particularly col. 11, line 5-10).

Hingorani et al. teaches atopic keratoconjunctivitis is a T-cell inflammation
prominent disorder (See particularly abstract). Hingorani et al. also teaches atopic

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keratoconjunctivitis may lead to infiltration and corneal involvement such as epithelial
keratitis (See particularly page 210, col. 1, last paragraph).

It would have been obvious to one skill in the art when the invention was made to
employ calcitriol, in ophthalmic solution dosage form, in a method to treat
keratoconjuctivitis, phlyctenular keratitis, or corneal infiltration. It would have been
obvious to one skill in the art when the invention was made to employ calcitriol in a
method to inhibit interleukin-1 production in cornea epithelium and thereby treat ocular
inflammation, which is the obvious therapeutic benefit herein recited.

One of ordinary skill in the art would have motivated to employ calcitriol, in
ophthalmic solution dosage form, in a method to treat keratoconjuctivitis, phlyctenular
keratitis or corneal infiltration. It is known that calcitriol inhibits the production of LC
migration inducing agent, TNF-ct. Employing agents that can block the LC migration,
such as calcitriol, to the inflammation site, such as in the cornea, and treating
keratoconjuctivitis would be reasonably expected to be useful. In addition, the cited prior
art provide additional motivation to employ calcitriol in the instant treatment method
because it is known that atopic keratoconjunctivitis is a T-cell inflammation prominent
disorder and may lead to infiltration and corneal involvement such as epithelial keratitis.
Therefore, employing any T-cell proliferation inhibitor, including calcitriol, would have
been reasonably expected to treat keratoconjunctivitis and keratitis, including
phlyctenular keratitis or corneal infiltration, thereby.

Furthermore, one of ordinary skill in the art would have motivated to employ
calcitriol in a method to inhibit interleukin-1 production in cornea epithelium and thereby

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treat ocular inflammation because calcitriol is known to inhibit the production of
interleukin-1a at a presecretory level by reducing the level of interleukin-1<x mRNA.
One of ordinary skill in the art would therefore reasonably expect calcitriol be useful in
inhibiting the production of interleukin-1 and reducing the function of LC and LC induced
activation of T cells, thereby decreasing the inflammation response and treating ocular
inflammation. Examiner notes that although the cited prior art do not teach the recited
properties of calcitriol, i.e., treat ocular inflammation without lowering transparency of
the cornea, such properties must be present in the compounds since the compounds
and its properties are not separable.

Response to Arguments

Applicant's arguments filed November 22, 2003 averring the cited prior art's
failure to teach treat ocular inflammation without lowering transparency of the cornea
have been fully considered but they are not persuasive. As discussed above, products
of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Therefore, if the prior art
teaches the identical chemical structure, the properties applicant discloses and/or
claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
See MPEP 21 12.01. In the instant case, calcitriol is considered to have such instrinsic
properties, absent evidence to the contrary.

Applicant's amendment necessitated the new ground(s) of rejection presented in
this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP

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Art Unit: 1617

§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
CFR 1.136(a).

A shortened statutory period for reply to this final action is set to expire THREE
MONTHS from the mailing date of this action. In the event a first reply is filed within
TWO MONTHS of the mailing date of this final action and the advisory action is not
mailed until after the end of the THREE-MONTH shortened statutory period, then the
shortened statutory period will expire on the date the advisory action is mailed, and any
extension fee pursuant to 37 CFR 1 .136(a) will be calculated from the mailing date of
the advisory action. In no event, however, will the statutory period for reply expire later
than SIX MONTHS from the date of this final action.

Any inquiry concerning this communication or earlier communications from the
examiner should be directed to San-ming Hui whose telephone number is (703) 305-
1002. The examiner can normally be reached on Mon 9:00 to 1 :00, Tu - Fri from 9:00 to
6:00.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Sreeni Padmanabhan, PhD., can be reached on (703) 305-1877. The fax
phone number for the organization where this application or proceeding is assigned is
(703) 872-9306.

Any inquiry of a general nature or relating to the status of this application or
proceeding should be directed to the receptionist whose telephone number is (703) 308-
1235.

Application/Control Number: 09/623,138

Art Unit: 1617

Page 7

San-ming Hui
Patent Examiner